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Browse Drug Recalls

383 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 383 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 383 FDA drug recalls.

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DateProductReasonClassFirm
Jun 2, 2015 Vitatrim Injection, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Ph... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Tri-Mix (18/0.6/5.88) (MFG) Injectable, Sterile, Keep Frozen, The Compounding... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Alprostadil 10 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharma... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Cholecalciferol 50,000 IU/ml Injectable, Vial, Sterile, Refrigerate, The Comp... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Morphine 33 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharma... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Morphine 40 mg/ml + Clonidine 500 mcg/ml Solution, Sterile-Preservative Free,... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Dexpanthenol 215 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, Th... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Dexpanthenol 250 mg/ml Injectable, ml Multi-Dose Vial, Sterile, Refrigerate, ... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Tri-Mix Injectable, The Compounding Pharmacy of America, Knoxville, TN Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Copper (Cupric)Sulfate 2 mg/ml Injectable, Multi-Dose Vial, Sterile, Refriger... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Estradiol 6 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Kn... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Morphine 40 mg/ml + Bupivacaine 16 mg/ml Solution, Sterile-Preservative Free,... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 HCG 2,500 IU/ml + Methylcobalamin 500 mcg/ml, Injection, Multi-Dose Vial, Ste... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Sermorelin 1000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO N... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 HCG 4,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compound... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Tri-Mix T-50/PGE 1 0.14/0.08 Injectable, The Compounding Pharmacy of America,... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Acetyl-L-Carnitine 250 mg/ml Injectable, Sterile-Multi-Dose Vial, The Compoun... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Fentanyl 1,000 mcg/ml + Bupivacaine 25 mg/ml Baclofen 500 mcg/ml + Clonidine ... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Zinc Chloride 25mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The ... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 LIPO-VITE Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compound... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Methylcobalamin 10 mg/ml + 5 Methyl Tetrahydrofolate 4 mg/ml Injectable, Ster... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 HCG 1,200 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compound... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Sodium Ascorbate 500 mg/ml Injection, Preservative Free Vial, Sterile, Refrig... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Hydromorphone 70 mg/ml + Bupivacaine 20 mg/ml + Clonidine 125 mcg/ml Intrathe... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Estradiol 100 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxvi... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Sermorelin 1000mcg/GHRP6 1000/GHRP2 1000 ml Injection, Multi-Dose Vial, Ste... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Estradiol 12.5 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxv... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Morphine 45 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharma... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Estradiol 22 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., K... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Hydromorphone 10 mg/ml Intrathecal Solution, Sterile-Preservative Free, The C... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 HCG 11,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compoun... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Morphine 50 mg/ml + Fentanyl 2,000 mcg/ml + Bupivacaine 10 mg/ml Clonidine 20... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Morphine 45 mg/ml + Bupivacaine 8 mg/ml + Baclofen 25 mcg/ml Solution, Steril... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Tri-Mix (30/1/20) Injectable, The Compounding Pharmacy of America, Knoxville, TN Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Testosterone 50 mg Pellet, Sterile, The Compounding Pharmacy of America, Inc.... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 PGE 150 (Alprostadil) 150 mcg/ml, ml, Multi-Dose Vial, Sterile, Keep Frozen, ... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Testosterone USP Aqueous 200 mg/ml Injection, Multi-Dose Vial, Sterile, Room ... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Morphine 40 mg/ml + Bupivacaine 8 mg/ml Solution, Sterile-Preservative Free, ... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Hydromorphone 12.5 mg/ml Solution, Sterile-Preservative Free, The Compounding... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 MIC-B COMPLEX Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Com... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Morphine 35 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharma... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Tri-Mix (20/1/10) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy ... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Methylcobalamin 5,000 mcg/ml Injectable, Multi-Dose Vial, Sterile, Refrigera... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Testosterone Cypionate 200 mg/ml Anastrazole 0.5 mg/ml Injection, Multi-Do... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Morphine 60 mg/ml + Fentanyl 12,000 mcg/ml + Bupivacaine 40 mg/ml + Clonidine... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 HCG 625 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 23 DAY KIT, T... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 HCG 1,100 IU/ml + Methylcobalamin 0.5 mg/ml Injection, ml Multi-Dose Vial, St... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Fentanyl 2,000 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The ... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Testosterone Cypionate 100 mg/ml Injection, Multi-Dose Vial, Sterile, Room Te... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Testosterone 30 mg, Sterile Pellet, The Compounding Pharmacy of America, Knox... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.